MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PRO; DEFIBRILLATOR

Model Number	AED PRO
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during incoming inspection testing, the device prompted a "unit failed" message.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the device was returned to zoll medical corporation; evaluation of the device was not required.Per customer communication the device performed to specification.It was determined the electrode pads being used at the time of the reported event were the cause of the reported malfunction.Evaluation of the electrode pads confirmed there was a faulty sensor puck, causing the device to fail self-test in non-rescue mode.Therefore this claim is being closed as evidence/communication supports report was unsubstantiated.Analysis for reports of this type has not identified an increase in trend.Reports of this nature are typically not considered to be medwatch reportable as the "unit failed" message occurred in non-rescue mode, which indicates that the device would still function in rescue or clinical mode.
Event or Problem Description
Complainant alleged that during incoming inspection testing, the device prompted a "unit failed" message in non-rescue mode.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: AED PRO
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7161441
• Report Number: 1220908-2017-03413
• Device Sequence Number: 19194425
• Product Code: MKJ
• UDI-Device Identifier: 00847946015121
• UDI-Public: 00847946015121
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: AED PRO
• Device Catalogue Number: AED PRO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1